four pages for each - )) ...................... 9 Resources ........................................................................................................................................... 22 Research Plan 23 Introduction to RevisedApplication (Not to exceed 3 pages) .................................................................................................................. Introduction to SupplementalApplication (Not to exceed one page) ....................................................................................................... 23 A. Specific Aims ............................................................................ _'1" ......................................................................................... J"" 24 B. Backgroundand Significance.................................................... """t"....................................................................................... t'" 26 C. PreliminaryStudies/ProgressReport/ _;=,.(Items A-D: not to exceed 25 pages*) .._ Phase I ProgressReport (SBIRISTTR Phase II ONLY) I SBIFUSTTRPhase/: Items A.D limitedto 15 pages. I D, Research Designand Methods................................................. _ .......................................................................................... 34 E. Human Subjects........................................................................................................................................................................... 46 Protectionof Human Subjects(Required if Item 4 on the Face Page is marked "Yes") Inclusionof Women (Required if Item4 on the Face Page is marked"Yes") .......................................................................... Inclusion of Minorities(Required ir Item 4 on the Face Page is marked "Yes") ........................................................................ Inclusionof Children(Required if Item 4 on the Face Page is marked =Yes").......................................................................... Data and SafetyMonitoringPlan (Required if Item4 on the Face Page is marked "Yes" anda Phase I, I1,or Ill clinical tdalis proposed................................................................................................................................................................. F. VertebrateAnimals....................................................................................................................................................................... 46 G. LiteratureCited............................................................................................................................................................................. 46 H. Consortium/ContractuaAl rrangements ........................................................................................................................................ 51 I. Consultants.................................................................................................................................................................................. 51 J. Product Development Plan (SBIR/STTR Phase II and Fast-Track ONLY) .................................................................................. Checklist ............................................................................................................................................. 52 Check if Appendix (Five collatedsets. No page numbetfngnecessary forAppendix.) Appendixis Included AppendicesNO T PERMITTED for Phase I SB/R/STTR unlessspecilfcaliysolicited. Number of publicationsand manuscriptsacceptedfor publication (not to exceed 10) 10 Other items (list): 1. Color illustrations from the grant application 2. Movies - intravital videomicroscopy supplement